An observational study in Hepatitis C, sponsored by Cerrahpasa Medical Faculty Foundation. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Cerrahpasa Medical Faculty Foundation · Observational
This is a retrospective, non-interventional study. Investigators from infectious diseases and gastroenterology departments will participate this study.
Patients data will be collected from hospital medical records.
Pangenotypic Sofosbuvir/Velpatasvir/Voxilaprevir for 8-12 weeks has been shown highly effective, safe, and well-tolerated in treating patients with chronic HCV infection in clinical trial settings, however, there are no real-world setting data are available.This is the first opportunity from all over the world to demonstrate SOF/VEL/VOXs efficacy and safety in Real World setting especially for the naive patients.
SOF/VEL/VOX is often positioned in retreatment by international guidelines. Previously the reimbursement guideline in Turkey did not allow patients to be re-treated after the failure of DAA treatments. With current guideline Vosevi is approved as the only option for failures of DAA treatments. In the past years in Turkey, SOF+RBV in GT2, SOF+PEF+RBV in GT3, LDV/SOF in GT1.4-6 patients and Viekirax/Exviera in GT1,4 patients have been used and unfortunately, some patients did not benefit from these suboptimal treatments. The efficacy and safety of SOF/VEL/VOX in patients who have experienced treatment failure in real life will be another objective of the research.
This research will support
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 450 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →This is the only study on the registry with Cerrahpasa Medical Faculty Foundation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
All CHC patients who received Soforbuvir/Velpatasvir/Voxilaprevir combination therapy will be included in this study. The information of these patients will be recorded retrospectively from the Hospital registry system.
Exclusion Criteria:
Sustained Virology Response 12
Rate of the patients with undetectabled HCVRNA after 12 weeks of the completion of SOF/VEL/VOX treatment
Time frame: From start date of treatment to 12 weeks after the completion of treatment
Plan to share: No
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